Clinical trials: Antibiotic Resistance, Bacterial
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
Staphylococcal Infection
Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"
The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired…
- Trial name
- NCT00729937
- Testing
- Cephalexin, Clindamycin, Trimethoprim-sulfamethoxazole
- Where
- 5 sites in United States
- Volunteers
- 2,265 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Helicobacter Infections
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication.
- Trial name
- NCT00669955
- Testing
- Omeprazole, amoxicillin, clarithromycin, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
- Where
- United Kingdom
- Volunteers
- 440 people
- Sponsor
- Forest Laboratories
Gonorrhoea
Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female subjects, between the ages of 18 and 55, who are in good health and meet all eligibility criteria.
- Trial name
- NCT02257918
- Testing
- AZD0914, Ceftriaxone
- Where
- 5 sites in United States
- Volunteers
- 180 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers, Anti-Bacterial Agents
A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers
To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin® SAL200 following single and multiple ascending doses in healthy male volunteers after continuous intravenous infusion over 60 minutes.
- Conditions
- Healthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus Infection
- Trial name
- NCT03446053
- Testing
- N-Rephasin® SAL200
- Where
- South Korea
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
Vancomycin Resistant Enterococci Infection, Clostridium Difficile Infection
Hospital Design and Risk of Nosocomial Infections: A Prospective Controlled Trial
With the construction of a new medical teaching ward with features designed to reduce hospital-acquired infections, we hypothesized that the design of the new ward was the major factor that contributed to the improved outcomes…
- Conditions
- Vancomycin Resistant Enterococci Infection, Clostridium Difficile Infection, Nosocomial Infection, Methicillin Resistant Staphylococcus Aureus Infection (MRSA)
- Trial name
- NCT00563186
- Testing
- Admission to a novel hospital ward
- Where
- Canada
- Volunteers
- 1,514 people
- Sponsor
- University of Calgary
Urinary Tract Infection
The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"
The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period.
- Trial name
- NCT01595529
- Testing
- Cefixime, Cephalexin, Trimethoprim/Sulfamethoxazole
- Where
- United States
- Volunteers
- 717 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Child Development
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome.
- Trial name
- ARMCA (NCT03187834)
- Testing
- Azithromycin, Amoxicillin, Cotrimoxazole
- Where
- 2 sites in United States, Burkina Faso
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
- Trial name
- CAP (NCT00509106)
- Testing
- Ceftaroline fosamil for Injection, Ceftriaxone
- Where
- 134 sites in United States, Argentina and 13 more
- Volunteers
- 622 people
- Sponsor
- Forest Laboratories
Healthy Volunteers, Anti-Bacterial Agents
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers
The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.
- Conditions
- Healthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus
- Trial name
- NCT01855048
- Testing
- N-Rephasin® SAL200
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- cSSSI (NCT00424190)
- Testing
- IV Vancomycin plus IV Aztreonam, Ceftaroline
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 698 people
- Sponsor
- Forest Laboratories
Bacterial Resistance
Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics
1. Background: Over 1 million intravitreal injections are performed annually in the United States. The most devastating complication related to these injections is endophthalmitis, with an incidence of 0.02 - 0.1% per injection.
- Trial name
- NCT02223338
- Testing
- Ciprofloxacin, Standard Aseptic Technique
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Loma Linda University
Staphylococcal Skin Infections
Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin.
- Trial name
- DAPHEOR1006 (NCT01419184)
- Testing
- Daptomycin, Vancomycin
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 250 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Infections
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant…
- Trial name
- NCT01645735
- Testing
- Ceftaroline fosamil, Ceftriaxone plus vancomycin
- Where
- 31 sites in United States, Georgia and 6 more
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Healthy Volunteers
Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.
- Trial name
- NCT01473368
- Testing
- Saccharomyces boulardii, Amoxicillin Clavulanate
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
- Trial name
- CAP (NCT00621504)
- Testing
- Ceftaroline fosamil for Injection, IV Ceftriaxone, Clarithromycin
- Where
- 168 sites in United States, Argentina and 21 more
- Volunteers
- 606 people
- Sponsor
- Forest Laboratories
Human Gut Microbiota
Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers.
- Trial name
- NCT01414010
- Testing
- Trametes versicolor extract, Saccharomyces boulardii, Amoxicillin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Staphylococcus Aureus Bacteremia, Anti-Bacterial Agents
Phase IIa Clinical Study of N-Rephasin® SAL200
This study is performed to evaluate safety and to explore the efficacy of a single intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard treatment, for persistent Staphylococcus aureus…
- Trial name
- NCT03089697
- Testing
- N-Rephasin® SAL200
- Where
- 2 sites in South Korea
- Volunteers
- 25 people
- Sponsor
- Intron Biotechnology, Inc.
Mycobacterium Infections, Nontuberculous
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary…
- Trial name
- OPTIMA (NCT03421743)
- Testing
- Inhaled molgramostim, Antimycobacterial regimen
- Where
- 5 sites in Australia, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Savara Inc.
Bacteremia, Sepsis
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in…
- Trial name
- NCT05314816
- Testing
- Blood culture identification panel
- Where
- Guatemala
- Volunteers
- 479 people
- Sponsor
- University of Colorado, Denver